SIMBRINZA® Suspension BID as an Adjunctive to Prostaglandin Analogue (PGA)

Additive Effect of Twice Daily Brinzolamide 1%/Brimonidine 0.2% Fixed Dose Combination as an Adjunctive Therapy to a Prostaglandin Analogue

The purpose of this study is to evaluate the additive intraocular pressure (IOP) lowering effect of brinzolamide 1%/brimonidine 0.2% (dosed twice per day (BID)) when added to a prostaglandin analogue (PGA) in subjects with open-angle glaucoma or ocular hypertension.

This study consisted of 2 sequential phases: Screening/Eligibility Phase, followed by a Masked Treatment Phase (Phase II). Subjects were assigned into one of 3 PGA therapy groups for the duration of the study, based upon commercial availability.

Inclusion Criteria:

• Diagnosis of either open-angle glaucoma or ocular hypertension;
• Must sign an informed consent form;
• Mean IOP measurements at both the Eligibility 1 and 2 visits, in at least 1 eye (the same eye[s]) ≥ 19 and < 32 mmHg at 09:00.
• Willing and able to attend all study visits;
• Other protocol-specified inclusion criteria may apply.

Exclusion Criteria:

• Women of childbearing potential who are pregnant, breast-feeding, intend to become pregnant during the study, or not using adequate birth control methods to prevent pregnancy throughout the study;
• Any form of glaucoma other than open-angle glaucoma or ocular hypertension;
• Ocular disease, trauma, infection, inflammation, pathology, or surgery as specified in the protocol;
• Any other conditions including severe illness which would make the subject, in the opinion of the Investigator, unsuitable for the study;
• Other protocol-specified exclusion criteria may apply.